OIS-AAO Las Vegas 2015

A BETTER, SAFER CAPSULOTOMY FOR EVERY CATARACT SURGEON

& PATIENT AROUND THE WORLD

ZEPTOTM

• Innovative, disposable device for cataract surgery

• Precision-pulse technology

• Accurate, reproducible capsulotomy that is quick, safe, and affordable

ZEPTOTM capsulotomy system

Disposable handpiece & console

Capsulotomy tip

Soft, clearsuction cup

Nitinol capsulotomy ring

Incision finder

ZEPTOTM capsulotomy

ZEPTOTM capsulotomy

Chamber safety -temperature

2.94 secs; 1.760 C

2.69 secs; 0.890C

A

B

No significant temperature change in eye

• Low energy capsulotomy• Additional shielding by silicone cup

4.47 secs; 0.530C

4.60 secs; 1.320C

3.59 secs; 1.910 C

3.69 secs; 2.010 C

duration; peak

Zonular safety

CCC ZEPTOPaired human cadaver eyes

Edge strength – CCC vs ZeptoTM

CCC

ZEPTO

Paired human cadaver eyes

16 mN

60 mN

Tear Strength

Edge strength ZeptoTM vs Femto & CCC

0

20

40

60

80

100

120

140

160

180

200

Pair9 Pair10 Pair11 Pair12 Pair13 Pair14 Pair15 Pair16

EdgeTearStreng

th(m

N)

PrecisionPulseCapsulotomy

CCC

Wilcoxon matched-pairssigned-ranks test P = 0.012

Paired cadaver eyes

Wilcoxon matched-pairssigned-ranks test P = 0.012

ZeptoFemtosecond Laser

ZeptoCCC

Bottom edge ofcapsulotomy ring

Lens capsule at rest

Precision-Pulse Capsulotomy

Suction applied, capsulepulled against ring edge

Increased tensile stress

Trapped water molecules

Cross-section through device and capsule

Multipulse energy discharges

Rapid phase transition ofwater molecules

Capsule membrane cleaved precisely

Scanning Electron Microscopy (SEM)

ACut edge

Functional edgeduring surgery

D CCC

B ZEPTOSchematic

C ZEPTO

20 microns

Small Pupil

3rd Party Assessment of ZeptoTM

DYMEDEX Scientific data driven market analysis, market adoption, & expected forecast for medtech companies.

• Uses only hard facts – peer reviewed literature, disease & patient landscape, govt. & other databases.

• Epidemiology statistics, behavior change theory & validated statistical engines.

• Clients: Medtronic, Covidien, Boston Scientific, St. Jude Medical……

• Over 150 companies analyzed – 80% accuracy

Engaging The Early Majority

Early Adopters (13.5%)

Innovators (2.5%)

Early Majority (34%):• Comfortable with incremental improvements• Need references from reputable sources and peers (Guidelines)• Need to see the value/evidence• Don’t want to help fix the product

• Will self-adopt if all their needs are being met

Dissect Patient Segments

Start with hard facts:

• Ex. Patients with pseudoexfoliation syndrome (PEX) or small pupils have the highest risk for posterior capsule rupture.

Analysis Highlights

Dedicated team, 4 mos - Cataract space well described - Highly confident in results

• Zepto is a compelling product with very few barriers to adoption.

• Quick adoption very likely for compelling patient segments (i.e., co-morbidities).

• Initial segments = 25% of patients common to nearly all practices. Therefore rapid penetration to Milestone 1 (access to early majority).

• Ease of use will spread to many practices. Broad adoption as standard of care highly achievable with standard marketing and selling elements (Milestone 2).

• The Zepto price point supports utilization in up to 70% of procedures.

Market Sizing & Projections

• 5 yr. revenue $386M US $ 159M EU $ 227M

• ROW* not included (fast growing market for phacosurgery)

* Economically viable for phacoemulsification

• Forecast does not include Zepto integration into a phaco system.

• Enhances the marketability of associated products - phaco machines, packs, OVD, Premium IOLs.

RegionCataract

PrevalenceNo. Phaco Rx

2015

US 54M 3.1M

Euro-22 91M 4.9M

ROW 282M 16.8M*

100+ In-Person Physician Meetings

100+ physicians from US and EU

@ Hawaiian Eye, ASCRS, AECOS, ESCRS

Individual 30-60 min sessions.

• 95% femto users

• ALL will use ZeptoTM in their practice

• See ZeptoTM and femto as complementary

• >50% expressed desire to help company

• Universal agreement on immediate patient populations

+Device Update

Handle is modeled after a vitrectomy cutter

Device will have surgeon controlled extension and retraction

Lighter power cord and single suction tube

Suction cup remodeled with donut style cup to allow for 2.2mm incision

+Power Console Update

Generation 2 Power Console being manufactured in Tijuana

OnCore working on 3rd generation design changes

OIS-AAO Las Vegas 2015